Dry Eye Inflammation (MMP-9) · the clinical signs of dry eye.2 InflammaDry is the first rapid,...

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Dry Eye Inflammation (MMP-9) Quidel | Eye Health | quidel.com | 800.874.1517 | 858.552.1100 Clinical benefits Pre-surgical measurements are more accurate and post-surgical outcomes are improved by identifying and treating patients with dry eye. 3 Reduce post-surgical complications, such as corneal wound healing, by identifying dry eye prior to surgery. 1 Therapeutic treatment of dry eye improves patient quality of life. 4 Fast and accurate Results as soon as 10 minutes. Higher positive and negative agreement than other dry eye tests. Easy and convenient Disposable test, requires just 4 easy steps. No additional equipment is needed to administer or interpret. According to the 2017 TFOS DEWS II Report, dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. 1 The lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Often times, inflammation is present before the clinical signs of dry eye. 2 InflammaDry is the first rapid, in-office CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. Other dry eye tests only measure tear production and stability. InflammaDry accurately identifies patients with dry eye allowing for optimal treatment methods and better quality of life. Have confidence in your diagnosis

Transcript of Dry Eye Inflammation (MMP-9) · the clinical signs of dry eye.2 InflammaDry is the first rapid,...

Page 1: Dry Eye Inflammation (MMP-9) · the clinical signs of dry eye.2 InflammaDry is the first rapid, in-office CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker

Dry Eye Inflammation (MMP-9)

Quidel | Eye Health | quidel.com | 800.874.1517 | 858.552.1100

Clinical benefitsPre-surgical measurements are more accurate and post-surgical outcomes areimproved by identifying and treating patients with dry eye.3

Reduce post-surgical complications, such as corneal wound healing, by identifyingdry eye prior to surgery.1

Therapeutic treatment of dry eye improves patient quality of life.4

Fast and accurateResults as soon as 10 minutes.

Higher positive and negative agreement than other dry eye tests.

Easy and convenientDisposable test, requires just 4 easy steps.

No additional equipment is needed to administer or interpret.

According to the 2017 TFOS DEWS II Report, dry eye is a multifactorial disease of the ocularsurface characterized by a loss of homeostasis of the tear film, and accompanied by ocularsymptoms, in which tear film instability and hyperosmolarity, ocular surface inflammationand damage, and neurosensory abnormalities play etiological roles.1

The lack of correlation between clinical signs and symptoms of dry eye disease makes diagnosing and treating patients a challenge. Often times, inflammation is present beforethe clinical signs of dry eye.2

InflammaDry is the first rapid, in-office CLIA-waived test that detects elevated levels ofMMP-9, an inflammatory marker that is consistently elevated in the tears of patients withdry eye disease. Other dry eye tests only measure tear production and stability. InflammaDryaccurately identifies patients with dry eye allowing for optimal treatment methods and better quality of life.

Have confidence in your diagnosis

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Page 2: Dry Eye Inflammation (MMP-9) · the clinical signs of dry eye.2 InflammaDry is the first rapid, in-office CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker

Positive

NOT FOR SALE IN THE U.S.

SL2501 | SS1024002EN00 (01/18)

4-Step Procedure

Performance Characteristics

Positive %Agreement

Negative %Agreement

InflammaDry – 20 Test Kit: Catalog #RPS-ID-20-UExternal Controls – Catalog #RPS-DESTD

To order, contact your Quidel Account Manager, call Customer Service at 800.874.1517, or visit quidel.com/InflammaDry

Collect sample Assemble test Run test Read results

Negative

Invalid

98%80.3%

The multicenter clinical study demonstrated the following range of performance from site to site or betweensites ranging from: Positive % Agreement 66% to 97% and Negative % Agreement 97% to 98%. At two sites,Negative Agreement could not be calculated because there were no subjects without dry eye.

Refer to the Package Insert for additional performance claims.

1Nelson J.D. et al. TFOS Dew II Introduction. The Ocular Surface. 2017 July; 15(3):269-275.2Sambursky R., O’Brien T.P. MMP-9 and the perioperative management of LASIK surgery. Curr Opin Ophthalmol. 2011 Jul 22; 22(4): 294-303.3Shtein R.M. Post-LASIK dry eye. Expert Rev Ophthalmol. 2011 Oct; 6(5): 575-582.4Schiffman R.M., Walt J.G., Jacobsen G. et al. Utility assessment among patients with dry eye disease. Opthalmol. 2003 Jul; 110(7): 1412-9.

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Page 3: Dry Eye Inflammation (MMP-9) · the clinical signs of dry eye.2 InflammaDry is the first rapid, in-office CLIA-waived test that detects elevated levels of MMP-9, an inflammatory marker

Positive

NOT FOR SALE IN THE U.S.

Tips for success with InflammaDry

1 Collect sample 2 Assemble test 3 Run test 4 Read results

Negative

Invalid

Quidel | Eye Health | quidel.com | 800.874.1517 | 858.552.1100

A Simple 4-Step Process to Aidin Dry Eye Diagnosis

Collecting the tear sample

To collect a tear sample, gentlydab the sample collector in 6-8 locations on the palpebral con-junctiva, until the fleece glistens(see tips below).

Snap the sample collector into theTest Cassette.

Press firmly where indicated whenassembling. A double-click meansthe test is properly assembled.

Immerse the absorbent tip into theprovided buffer vial for a minimumof 20 seconds until a purple fluidwave is observed moving across the result window.

Replace the protective cap and laythe test flat on a horizontal surface.

After 10 minutes, read the test results.

RED + BLUE = POSITIVEBLUE = NEGATIVE

Refer to the Package Insert for InflammaDry found on the InflammaDry product page under Product Documentation at: quidel.com/InflammaDry

Instruct the patient tolook up.

Gently lower the eye-lid to expose thepalpebral conjunctiva.

Dab the samplingfleece in multiple locations along theconjunctiva, releasingthe lid after every 2-3 dabs.

Allow the patient toblink.

After completing aminimum of 6-8 dabsalong the conjunctiva,allow the samplingfleece to rest on theconjunctiva for an additional 5 seconds,to ensure saturation.

Inspect the samplingfleece. The fleece willglisten when an ade-quate tear sample iscollected. Dependingon the patient’s tearcomposition, thefleece may also turnpatchy pink in color. If the fleece is NOTglistening, repeat the entire process.

A B C D E F

ImportantInflammaDry should be performed PRIOR to instilling ocular anesthetic, topical dyes, or performing Schirmer testing.If drops are used, wait 2 hours before collecting a tear sample.

Once opened, the Test Cassette should be used within 1 hour.

Reading the resultsWait a minimum of 10 minutes before reading test results.

If the test is negative after 10 minutes, allow an additional 5-10 minutes before reading test results.

Read any form of a red line, whether faint, broken, or shadow, as a positive test result.

SL2507| H

T1024000EN02 (10/17)

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